Suture with toggle and delivery system

ABSTRACT

The self securing suture includes a suture having at least one terminal end and a toggle, formed of suture material, at the suture&#39;s terminal end. In one embodiment, the suture toggle is a bar. In another embodiment the suture is a wire and the toggle is a wire element toggle. The wire element toggle is a double strand segment or an open loop segment. The suture delivery system includes a slotted needle configured such that a protruding tab or leg of the toggle bar fits within slot of the needle. For wire sutures, the open loop wire element toggle fits within the slotted needle. In another embodiment, a depending wire tip, from the wire element toggle, fits within the slot in the needle. In either situation, after the needle pierces the bodily structure, tissue or organ, the tab, leg, depending wire tip or open loop wire segment coacts with the inboard portion of the bodily structure, tissue or organ, and, as the delivery needle is withdrawn, the toggle at the terminal end of the suture remains in the bodily structure, tissue or organ. The toggle is then fully deployed being generally normally disposed (perpendicular) to the length or axial center line of the suture. When the suture has two suture toggles, one at each terminal end of a suture thread or suture wire body, the physician can easily deploy the suture toggles on either side of an arterial puncture site (for example), tie off the suture thread or suture wire body and thereby close the puncture.

This is a continuation patent application based upon patent applicationSer. No. 09/413,145 filed Oct. 6, 1999, is now U.S. Pat. No. 6,206,895,which was based upon provisional patent application Ser. No. 60/143,555filed Jul. 13, 1999.

BACKGROUND OF THE INVENTION

In order to pass a suture through a tubular organ or other structure ina body (a human body or an animal), it is necessary to traverse thebodily structure, tissue or organ completely and encircle the area wherethe physician or medical technician wishes to place the suture. Thistraverse and encircle method works well in situations where easy accessis available to the structure, tissue or organ and the item to besutured is easily viewed by the physician. In limited access situations(for example, in laposcopic surgery, cardiac surgery and vascularsurgery), the traverse and encirclement by sutures is often timesdifficult, dangerous and at other times impossible.

As a further example, an attempt to suture a blood vessel through asmall puncture wound is almost impossible. The direct suture of thearterial puncture is not possible.

The increasing utilization of minimally invasive surgical techniques hascreated a need for improved methods, suture systems and suture placementdevices under adverse conditions of limited access and limitedvisibility of the suture site.

U.S. Pat. No. 5,053,046 to Janese discloses a dural sealing needle. Thedural ceiling needle includes a gelatin sealing compound that swells andsits between an impact cone cavity and an impact cone protrusion. Wingsspread out based upon the swelling of the gelatin seal and assist in theretention of the suture seal. U.S. Pat. No. 5,860,990 to Nobles et al.discloses a suturing device which includes sutures having needle pointsat terminal ends of the suture wire. The sutures are made of NITINOLmemory shape metal material When the memory shape metal is freed fromthe lumen of a needle, the needle points, at the terminal ends of themetal sutures, flare out laterally beyond the lumen of the needle andthe needle points are captured by suture catches which are alsolaterally disposed outboard of the needle. The catches pull the needlepoints and draw in the sutures. U.S. Pat. No. 4,744,364 to Kenseydiscloses a tubular body at the end of a suture thread which expandsafter being pushed out from the lumen of a delivery needle. In thelumen, the body is contracted or compressed. U.S. Pat. No. 4,741,330 toHayhurst discloses an apparatus for anchoring cartilage. The anchor isdeformed in the lumen of a delivery tube, is thereafter pushed from thetube and springs laterally outward upon exiting the tube.

U.S. Pat. No. 4,705,040 to Mueller et al. disclose a T-shaped bar,having a length of 0.25 inches, at the end of a suture. The bar is heldin place by a melted ball of material at the terminal end of the suture.

OBJECT OF THE INVENTION

It is an object of the present invention to provide a suture which canbe self secured on a bodily structure, tissue or organ with a toggle atthe terminal end of the suture.

It is another object of the present invention to provide a generallyT-shaped toggle which latches on an interior or inboard surface of abodily structure, tissue and organ thereby permitting the balance of thesuture to be drawn in and wherein the toggle grasps the bodilystructure, tissue and organ.

It is a further object of the present invention to provide a toggleconfigured as a bar at the end of a suture.

It is another object of the present invention to provide a metal wiresuture with a T-shaped toggle or a toggle wire element attached to theterminal end of a suture wire.

It is a further object of the present invention to provide a suture anda suture toggle wherein the suture toggle includes a protruding leg ortab which is utilized by a needle delivery system to insert the suturetoggle into the bodily structure, tissue or organ.

It is a further object of the present invention to provide a suturedelivery system including a slotted needle, within which is seated theleg or tab of the suture toggle, which assists in the process ofinserting the suture toggle into the bodily structure, tissue or organ.

It is another object of the present invention to provide a self securingsuture with a suture toggle which can be used for minimally invasivesurgical techniques.

It is a further object of the present invention to provide a suturedelivery system and toggle sutures utilized in laproscopic procedures.

SUMMARY OF THE INVENTION

The self securing suture includes a suture having at least one terminalend and a toggle, formed of suture material, at the suture's terminalend. In one embodiment, the suture toggle is a bar. In anotherembodiment the suture is a wire and the toggle is a wire element toggle.The wire element toggle is a double strand segment or an open loopsegment. The suture delivery system includes a slotted needle configuredsuch that a protruding tab or leg of the toggle bar fits within slot ofthe needle. For wire sutures, the open loop wire element toggle fitswithin the slotted needle. In another embodiment, a depending wire tip,from the wire element toggle, fits within the slot in the needle. Ineither situation, after the needle pierces the bodily structure, tissueor organ, the tab, leg, depending wire tip or open loop wire segmentcoacts with the inboard portion of the bodily structure, tissue ororgan, and, as the delivery needle is withdrawn, the toggle at theterminal end of the suture remains in the bodily structure, tissue ororgan. The toggle is then fully deployed being generally normallydisposed (perpendicular) to the length or axial center line of thesuture. When the suture has two suture toggles, one at each terminal endof a suture thread or suture wire body, the physician can easily deploythe suture toggles on either side of an arterial puncture site (forexample), tie off the suture thread or suture wire body and therebyclose the puncture.

BRIEF DESCRIPTION OF THE DRAWINGS

Further objects and advantages of the present invention can be found inthe detailed description of the preferred embodiments when taken inconjunction with the accompanying drawings in which:

FIGS. 1A and 1B diagrammatically illustrate a suture with a suturetoggle;

FIGS. 2A and 2B diagrammatically illustrate a suture delivery needlewith and without the suture toggle;

FIGS. 3A, 3B, 3C, 3D and 3E diagrammatically illustrate the insertionand deployment of the suture toggle and, more particularly, FIG. 3Egenerally diagrammatically illustrates the size relationship between thesuture toggle and a typical large artery in a human body;

FIGS. 4A, 4B and 4C diagrammatically illustrate a suture delivery systemneedle, a suture toggle and a modified delivery system;

FIGS. 5A-5F diagrammatically illustrate various protruding legs, tabsand other elements protruding from the suture toggle which assist indeployment of the suture toggle in the bodily structure;

FIGS. 5G and 5H diagrammatically illustrate various suture toggles withdepending tabs;

FIG. 6 diagrammatically illustrates a suture having two terminal endsand two suture toggles;

FIG. 7 diagrammatically illustrates a suture with two suture toggles, atboth terminal ends of a suture thread, deployed about an arterialpuncture site;

FIGS. 8A-8C diagrammatically illustrate other suture toggles;

FIGS. 9A-9D diagrammatically illustrate a suture delivery system withand without a suture toggle;

FIGS. 10A and 10B diagrammatically illustrate the deployment of thesuture toggle illustrated in FIG. 8A;

FIGS. 11A, 11B and 11C diagrammatically illustrate other types of tabsprotruding from suture toggles;

FIG. 12 diagrammatically illustrates a suture toggle deployed in asuture delivery needle;

FIGS. 13A and 13B diagrammatically illustrate a suture toggle configuredas a cylinder with a protruding side leg;

FIG. 13C diagrammatically illustrates a suture toggle configured as anangled T-bar deployed in a neddle;

FIGS. 14A and 14B diagrammatically illustrate one delivery system forthe suture and suture toggle utilized in conjunction with minimallyinvasive surgery;

FIGS. 15A and 15B diagrammatically illustrate front and side views ofthe suture delivery needle;

FIGS. 16A, 16B and 16C diagrammatically illustrate variousconfigurations of the needle retention body or structure;

FIG. 16D is a cross-sectional view of the delivery system from theperspective of section line 16D′-16D″ in FIG. 14A;

FIG. 17 diagrammatically illustrates an arterial puncture site in alarge artery in a human;

FIG. 18 diagrammatically illustrates another type of suture deliverysystem;

FIG. 19 diagrammatically illustrates an exploded view of the suturedelivery system shown in FIG. 18;

FIGS. 20A, 20B, 20C and 20D diagrammatically illustrate cross sectionalviews of the delivery system shown in FIG. 19 from the perspective ofthe corresponding section lines in FIG. 19;

FIGS. 21A-21F diagrammatically illustrate various configurations of wiresutures and wire toggle elements;

FIGS. 22A-22D diagrammatically illustrate needle delivery systems forthe wire suture toggles;

FIGS. 23A-23C diagrammatically illustrate a laproscopic device for thesuture toggle delivery system and FIG. 23D is a cross-sectional view ofa suture wire capture system (similar capture systems may be used withsuture threads on the delivery systems in FIGS. 14A and 18);

FIGS. 24A-24C diagrammatically illustrate major operational steps todeploy suture toggles during laproscopic surgery with the deliverysystem shown in FIG. 23A; and,

FIGS. 25A, B, C and D diagrammatically illustrate a hooked wire suture.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to self securing sutures, that is, sutureshaving toggles at the suture's terminal end, and various suture deliverysystems.

FIGS. 1A, 1B, 2A and 2B diagrammatically illustrate sutures havingtoggles at the terminal end and a needle delivery system used inconjunction with the suture toggles. FIGS. 14A and 18 diagrammaticallyillustrate simple delivery systems for the suture toggles. FIGS. 21A, B,C, D, E and F show wire suture toggles and FIG. 23A shows a deliverysystem for laproscopic surgery or other type of surgery wherein thesurgeon seeks to suture fascia.

General Principles

By utilizing the toggle principle, it is possible to enter the bodilystructure, tissue or organ and fix one end of a suture to the structureor tissue without encircling the area. If two separate toggle suturesare fixated in this fashion, it becomes possible to tie those sutureswith ease without the need for blind encirclement of the area inquestion. The increasing utilization of minimally invasive surgicaltechniques and arterial puncture site repair has created a need forimproved methods of suture placement under adverse conditions ofvisibility and access.

The toggle principal lends itself well to the placement and fixation ofsutures, ligaments, etc. In this approach, a suture or wire or otherflexible attachment or closure device is passed through or into thetissue in a closed state. The “closed state” refers to the suture toggledeployed in the needle. Upon applying tension after the toggle leavesthe needle tip, the toggle is positioned so that it cannot retrace thepath through which it was applied or inserted by virtue of the fact thatits shape and position will no longer allow egress from the bodilystructure or tissue. Structures such as sutures or ligaments attached tothe toggle are thereby fixed. One general embodiment of this inventionconsists of a T-shaped attachment to the end of a suture of either thesame or different biocompatible material. The T bar is stiffer than thesuture line, thread or wire and offers significant resistance toextraction from the bodily structure once deployed. The suture toggledesign in fine wire allows the insertion of the toggle, but restrictsthe egress from the tubular structure. With respect to wire sutures,provision is made for the applying or delivery device to secure bothwires together and close the defect by shortening the wire by thesimple, but effective, expedient means of twisting the instrument andits contained wires to secure them together. Provision is made to scorethe wires at the appropriate location so that the wires divide orseparate upon twisting with a small, but secure, stub of twisted wire.In the alternative, a twisting and cutting instrument can be slid downthe two opposing wires after the applicator is removed and the wiresretained. This instrument would permit twisting and subsequent cuttingof the wires in a blind procedure.

Basic Details of Operation

The applying device or delivery system consists of a small hollow coreneedle which allows it to be passed over a guide wire which has beenretained at the puncture site. The delivery system contains two smallhollow needles in opposition at just the right distance on either sideof the guide wire and, thus, the puncture site. In another iteration,the needle can be solid with hollow small toggle suture ends fitted overthe needle rather than through them. In the first design, the needlesare designed to contain the toggles and the wire or sutures. When theinstrument is slid over the guide wire and through the skin incisionsite of puncture it is advanced until it is against the vessel orstructure sought to be closed by a suture. In the case of a vein orartery, a “flashback” tube can be utilized in advance of the needles todemonstrate that the instrument is in the proper position. In addition,the length and design of the “flashback tube” is such that it protectsthe far wall of the structure, preventing toggling of two wallssimultaneously. The restricted length of the hollow needles alsoprotects opposite walls of the artery or vein. A slide moves the twoneedles distally and then advances the needles through the vessel orstructure wall until the toggles are deposited in the blood vessel withtheir trailing suture or wire leading from the vessel. The hollow needlealso acts as a flashback tube bilaterally. The shape of the toggle, asdesigned, prevents egress from the vessel and traction on the wire orsuture “sets” the T of the toggle flush against or in the structurewall. The suture is then tied or the wire twisted as appropriate.

Different toggle designs are provided as shown in the accompanyingdrawings. In this fashion, puncture wounds or other defects may beeasily closed utilizing simple and inexpensive devices. The cost ofcomplicated closure devices has been a deterrent to the universalacceptance of these previous devices. The utilization of a simple,inexpensive disposable device should remove many of the impediments foruniversal useage. The concept of toggling sutures for closure is new,safe and simple to use.

In one of the embodiments presented here, fine, partially annealed wiresutures are utilized to simplify the process by permitting fastening bysimple twisting of the wires by the instrument, instead of having toresort to complex methods of tying. Scoring the wires at the appropriatedistance allows them to break with twisting at a predetermined locationleaving only a small wife stump on top of the structure.

Any biocompatible material for the suture and suture toggle may be usedsuch as stainless steel wire, nylon sutures, or other syntheticbiocompatible material. The methods of tying the sutures may vary withthe materials used, but the toggling principle remains the same.

FIGS. 1A and 1B diagrammatically illustrate a suture 10 having a suturethread or suture body 12, a terminal end 13 and a toggle 14. FIG. 1Bshows a side view of suture toggle system 10. In the illustratedembodiment, toggle 14 is generally a solid rectangular shape having alength 1, a width w (FIG. 1B) and a depth d. The width w of the toggle14 is substantially similar to the outside diameter of the suture thread12 as shown in FIG. 1B. Toggle 14 has chamfered ends and edges, one ofwhich is chamfer edge 15. This chamfer reduces sharp edges. Further,toggle 14 includes an extending leg 16 protruding outboard away fromterminal end 13 of suture 12. Extending leg 16 defines, in combinationwith toggle body element 18, an open catch mouth 20 leading to anarrower throat 21. Mouth 20 has a gap size large enough to be capturedby a slot in the delivery needle discussed later. Leg 16 protrudes in adirection opposite the attachment of suture 12 to toggle 14.

FIGS. 2A and 2B diagrammatically show a suture delivery system 8 whichincludes needle 24 having a lumen 26, a piercing terminal end 28 and anopen ended slot 30. Open ended slot 30, sometimes called a needle toggleslot herein, is open at the piercing end segment 28 of needle 24. In theillustrated embodiment, piercing terminal end segment 28 (typically asharp edge) of needle 24 is angularly disposed with respect to the axialcenter line of needle 24.

Toggle suture system 10 is shown as disposed in lumen 26 of needle 24 inFIG. 2B. Suture toggle 14, and particularly protruding leg 16, isadapted to seat within slot 30 of needle 24.

FIGS. 3A-3D diagrammatically illustrate basic operationalcharacteristics of suture toggle system 10. Similar numerals designatesimilar items throughout all the drawings. In FIG. 3A, suture deliverysystem 8, consisting of needle 24 loaded with suture 12 and suturetoggle 14, approaches a bodily structure, tissue or organ wall 31. As anexample throughout the drawings (excepting drawings FIG. 24A-24C),reference will be made to arterial wall 31. However, any type of bodilystructure, tissue or organ may be sutured using the suture toggle system10 discussed herein. Wall 31 is representative of other bodilystructures tissues and organs. Delivery system 8 approaches arterialwall 31 as shown by arrow 33. Piercing end 28 of needle 24 ultimatelypierces and enters arterial wall 31.

FIG. 3B diagrammatically shows that needle 24 has fully entered andpassed through arterial wall 31. At this point in time, blood flow isnoted by a “flash” from the lumen 26 of needle 24. Other “flash back”systems may be utilized. See central tube 62 in FIG. 14A. This flash ofblood provides a visual indication to the physician that the needle 24has fully penetrated into the lumen of the artery or other structure.

In FIG. 3C, the physician is withdrawing needle 24 and protruding leg 16of toggle 14 is caught on the inboard surface of arterial wall 31. InFIG. 3D, needle 24 is withdrawn from arterial wall 31 and toggle 14 andsuture 12 is self secured in artery wall 31.

FIG. 3E diagrammatically illustrates the general proportional sizerelationship between artery wall 31, the artery in general, toggle 14and suture 12. To further illustrate one proposed embodiment of thesuture toggle, the following Exemplary Dimensional Table is provided.

Exemplary Dimensional Table head length 0.10-0.12 mm head depth 0.020 mmOD suture 3/0 nylon suture length 18 inches head width 0.10-0.012 mm gap0.008 mm or more typical delivery needle 0.028 mm OD 0.023 mm ID 21gauge large artery size about 7 mm ID

FIG. 4A diagrammatically illustrates suture toggle 14 and suture thread12 disposed in needle 24. Protruding leg 16 is also disposed in slot 30.However, suture thread 12A is disposed outside of needle lumen 26. Thisis accomplished by providing a secondary slot 34 within which passessuture thread A. Secondary slot 34 is sometimes referred to herein as asuture slot in the needle.

FIG. 4B diagrammatically shows open ended suture slot 34 at terminal end29 of needle 24. Terminal end 29 of needle 24 is part of piercingterminal end 28. In the illustrated embodiment, suture slot 34 isopposite toggle slot 30 which retains, in a loaded mode, protruding leg16 of suture toggle 14. The position of the suture slot relative to thetoggle slot varies dependent upon the position of the protruding leg,tab, wire element or loop on the suture toggle.

FIG. 4C diagrammatically shows needle 24 within which is loaded suturetoggle 14. Protruding leg 16 protrudes towards suture thread 12A. Inthis illustrated embodiment, slot 30 also operates as a suture slot. Inaddition, needle 24 includes rib 36 which enables the suture needle tobe inserted into the blood vessel 31 by a pushing in action.

FIGS. 5A through 5H diagrammatically illustrate various modifications ofsuture toggle 14. FIG. 5A diagrammatically illustrates suture toggle 14having a protruding leg 16 which protrudes outboard from the toggleopposite suture thread 12. Particularly, toggle 14 is a toggle bar. Asused herein, the term “toggle” refers to a piece or a device for holdingor securing suture thread 12. The term “toggle” also encompasses theconcept that it is a cross piece attached to the end of suture thread 12in order to prevent slipping or removal of the suture. The following BarShape Table provides some illustrative examples of the geometric shapeof the toggle bar.

Bar Shape Table

a straight piece of suture material which is longer than it is wide

rectangular

oblong

elliptical

an elongated cylinder

As used herein, the term “bar” refers to a straight piece which islonger than it is wide. As shown in FIG. 5A, leg 16 is formed from apartially separated segment of toggle bar 14. Remaining segment 18continues to form part of the toggle bar basic shape.

FIG. 5B shows a depending protruding leg 38 which protrudes inboardtoward suture tread 12. Leg 38 is cut away or formed from toggle barsegment 39. Leg 38 is retained by and captured within open ended toggleslot 30 of needle 24. Gap 20 between leg 38 and toggle remainder section39 is one of the important features.

FIG. 5C diagrammatically illustrates toggle suture 14 including a tab 40depending from inboard surface 41 of suture toggle 14. Inboard surface41 is integral with or attached to suture terminal end 13. Surface 41 isinboard with respect to suture thread 12.

FIG. 5D diagrammatically shows tab 40 depending toward suture thread 12.FIG. 5D shows tab 40 consisting of either a solid triangular body, afinger or a conical body. The width of tab 40 is smaller than suturetoggle 14. Protruding tab 40 has a raised terminal edge 42, see FIG. 5E,which faces away from suture thread 12. Tab 40 coacts with open endedslot 30 of suture delivery needle 24 (see for example FIG. 4B). The tabfits in toggle slot 30. In a different embodiment, suture slot may beplaced 90 degrees from toggle slot 30 (see FIG. 9C) to provide clearanceof the tab from the thread during withdrawal of needle 24.

FIG. 5F diagrammatically illustrates suture toggle 14 carrying two tabs40, 43 depending from inboard surface 41 of suture tab 14.

FIG. 5G diagrammatically shows tab 40 as a solid triangular body. Suturetoggle 14 is also a solid rectangular body without chamfered edges.

FIG. 5H diagrammatically illustrates suture toggle 14 from theperspective of section line 5H′-5H″ in FIG. 5G. Tab 40 has a raisedterminal edge 42 which faces towards suture thread 14. Accordingly, thetab can either face away from suture thread 12 as in FIG. 5E or towardssuture thread 12 as in FIG. 5H.

FIG. 6 diagrammatically shows suture toggles 14 and 14 a disposed atopposite terminal ends of suture thread 12. Suture thread 12 has alength ls which is, in one embodiment, about 16-18 inches. FIG. 6 alsoshows that suture toggle 14 has been deployed beneath body layer 31.

FIG. 7 diagrammatically shows deployed suture toggles 14 and 14 a onblood vessel wall 31. The suture toggles are deployed beneath arterialwall 31. Arterial wall 31 is illustrated as having arterial puncturesite 44. Suture toggles tabs 14, 14 a are deployed on either side ofpuncture side 44. Suture thread 12 connects suture toggles 14, 14 a Inoperation, the surgeon or physician ties off suture thread 12 therebyclosing arterial puncture site 44.

FIGS. 8A, 8B and 8C diagrammatically illustrate suture toggle 14 with aprotruding leg 16 along one side. Particularly, FIG. 8A diagrammaticallyshows suture toggle 14 as a toggle bar with chamfers along its sideedges. One of the chamfers is identified as chamfer 15. A protruding leg16 is formed by partly separating toggle 14 from remaining togglesegment 18. This creates an open mouth 20 which is disposed in thetoggle slot in needle 30. See FIG. 2A.

FIG. 8B shows a top view of suture toggle 14 and clearly shows thatprotruding and extending leg 16 is formed by partially separating leg 16from the remaining toggle body portion 18. The generally solid bodyrectangular toggle bar 14 has sides 2, 3, 4 and 5 which are generally inparallel planes with respect to the axial centerline of suture thread 12if the thread were laid out straight. Items protruding from toggle barwalls 2, 3, 4, 5 are normal (perpendicular) to the suture thread.

FIG. 8C shows a toggle end view and toggle mouth 20.

FIGS. 9A-9D show needle 24 with and without a retained toggle suture.FIG. 9A shows toggle slot 30 in needle 24 located approximately midwayalong piercing terminal edge 28 of needle 24. The toggle slot can bere-positioned dependent upon the size of the suture, the leg or tab, andthe item to be sutured. FIG. 9B also shows toggle slot 30 of needle 24approximately midway along needle piercing edge 28. FIG. 9B also showssuture toggle 14 deployed in toggle slot 30. Suture thread 12 runs orpasses through the lumen 26 of needle 24.

In FIG. 9B, slot 30 retains protruding leg 16 which protrudes from sideedge 5 of the toggle bar. The side edge protruding leg 16 is shown inFIGS. 8A-8C. Leg 16 protrudes normal or perpendicular to suture thread12.

FIG. 9C shows needle 24 having toggle slot 30 and suture thread slot 34.Suture thread slot 34 is formed or created approximately 90 degrees fromtoggle slot 30.

FIG. 9D shows suture toggle 14 with a side end protruding leg 16 whereinsuture thread 12 runs through suture slot 34 of needle 24.

FIG. 10A shows suture toggle 14 deployed in arterial wall 31.

FIG. 10B is a detailed view showing suture toggle 14 deployed on aninboard surface of arterial wall 31. Currently, it is believed that thetoggle bar with a leg or tab protruding from bar side 2, 3, 4 and 5 ispreferable.

FIG. 8B shows toggle bar 14 with side surfaces 2, 3, 4 and 5. It iscurrently believed that a tab or leg protruding from one of the sidesurfaces is better suited than an outboard extending tab or leg (seeFIG. 5A) or a depending tab or leg (see FIG. 5B). The depending leg orthe depending tab may injure an arterial 31 in certain situations. Whentoggle anchoring is required, the depending leg or wire is preferred. Anupstanding or outboard tab or leg may impede blood flow. However, insome applications, these tab-leg configurations may be beneficial if itachieves better attachment by the suture toggle on the body structure,tissue or organ. A side leg or tab is currently thought to be betterthan an outboard leg or tab (see outboard leg 16 in FIG. 1A) because anoutboard protruding leg or tab may further complicate and impede bloodflow or fluid flow through the bodily structure, tissue or organ,particularly if the structure is an artery or a vein.

FIG. 11A diagrammatically shows suture toggle 14 having a protruding tab40 protruding from side surface 5 of the toggle bar.

FIG. 11B shows protruding legs or arms 50, 51 protruding from sidesurface 5 of toggle bar 14. A plurality of legs or tabs may be utilized.FIG. 11C shows toggle 14 with a generally planar triangular tab 40protruding from side face 5. Tab 40 in FIG. 11A is generally conical instructure with squared off surfaces. Tab 40 in FIG. 11C is generally aplanar triangle.

FIG. 12 shows suture toggle 14 with a triangular tab deployed within thelumen of delivery needle 24. Tab 40 of toggle 14 protrudes from toggleslot 30. Suture 12 is deployed such that it exits lumen 26 of needle 24near proximal edge region 52 of piercing terminal edge 28 of needle 24.Proximal region 52 may be rounded or smoothed to avoid cutting suturethread 12.

FIG. 13A and 13B diagrammatically illustrate suture toggle 14 configuredas a cylindrical bar with a laterally protruding leg 16. Leg 16 is alsocylindrically shaped and protrudes laterally from toggle bar element 18.Leg 16 is generally normal to suture thread 12. Leg 16 is not cut fromor separated from the cylindrical toggle bar.

FIG. 13C diagrammatically illustrates toggle bar 14 at an angle 9 withrespect to the axial centerline of suture thread 12. In thisconfiguration, the acute angle 7 between angled toggle bar 14 and suturethread 12 is disposed within suture slot 30 of needle 24. This angulatedconfiguration may enable long T-shaped bar deployment in needle 24. Theterm “long T-shaped” refers to the length of sides 3,5 (see FIG. 8B)relative to the cross-sectional dimension of suture thread 12. Thisimplementation may also avoid the use of protruding legs, tabs ormembers.

FIGS. 14-20 diagrammatically illustrate various suture delivery systems.

FIG. 14A diagrammatically shows suture delivery system 60 which includesa basic or central tube 62 which runs over a guide wire 64. Guide wire64 typically is not part of the suture delivery system. The illustrateddelivery system in FIG. 14A is used to close puncture wounds made duringcatheterization. Guide wires 64 are used during such medical procedures.For purposes of explanation, suture delivery needles 66, 68 carry suturetoggles and suture threads generally shown and discussed earlier inconnection with FIGS. 1-13.

FIG. 15A shows suture needle 66 having a piercing edge 67 and a toggleslot 69. FIG. 15B diagrammatically illustrates a side view of sutureneedle 66.

Returning to FIG. 14A, base tube 62 rides over guide wire 64 in order toproperly place suture needles 66, 68 on either side of arterial puncture44 shown in FIG. 7. Suture needles 66, 68 have piercing ends 67, 67 awhich are laterally deployed a distance 69 from base central tube 62. Inthis suture delivery system, suture needles 66, 68 are made of metalhaving a shape memory such that when needle end segment 70 is free fromneedle containment or retaining structure 72, the distal ends of needles66, 68 spring laterally outward a distance 69.

Needles 66, 68 run and protrude through needle retainer body 72 and alsoprotrude proximally from proximal end 74 of retainer 72 towards thumbnut set 76. Proximal needle ends 75, 77 for needles 66, 68 are generallynear thumb nut set 78.

Needle retention structure 72 has a proximal tube member 80 such thattube 80 runs over central tube 62. The operator moves needle retainerstructure 72 by moving thumb nut set 78 in the direction shown by arrow82. As shown in FIG. 16D, proximal tube 80 (attached to needle retainerbody 72) has longitudinal slots 73 a, 73 b. Needles 66, 68 are attachedto base or center tube 62. Hence, when tube 62 is stationary and needleretainer 72 is moved, needles 66,68 are either exposed (FIG. 14A) orfully retained and covered (FIG. 14B).

FIG. 14B shows that needle retaining structure 72 has been pushedforward such that proximal ends 75, 77 of needles 66, 68 are proximateor near thumb nut set 78. Piercing edges 67, 67 a are disposed at, nearor below distal edges 79, 81 of needle retention structure 72. When thestructure delivery system 60 is placed on guide wire 64 and placed neararterial puncture site 44 (FIG. 17), thumb nut set 78 (mounted on tab 80and retainer 72) is then withdrawn in a direction opposite arrow 82 inFIG. 14A, and distal end 70 of needles 66, 68 are then exposed andsprung laterally outward due to the memory shape of the needles. Thesurgeon then places the distal end of tube 62 into arterial puncture 44(FIG. 17) and continues to move delivery system 60 down guide wire 64until he or she sees a flash of blood when piercing ends 67, 67 a ofneedles 66, 68 pierce arterial wall 31. A flashback may also occurthrough base tube 62. Toggle insertion generally occurs at sites 83, 85(FIG. 17). The surgeon then withdraws the needles thereby leaving thetoggle ends of the sutures on the inside arterial wall 31. The surgeoncan then close the arterial puncture after removal of guide wire 64 in amanner described above in connection with FIG. 7.

FIGS. 16A, 16B and 16C show different structures for needle retentionstructure 72. In FIG. 16A, retention structure 72 is generally circularin configuration. The structure contains left and right passages 82, 84within which pass needles 66, 68. A central passage 86 permits passageof base tube 62.

In FIG. 16B, needle retention structure 72 is elliptical or oblong. InFIG. 16C, needle retention structure 72 includes a central cylindricalbody 88 and two side bodies 90, 92. Side body 90 has a lumen throughwhich passes needle 66. Side body 92 includes a lumen through whichpasses needle 68. Central body 88 includes a lumen through passescentral or base tube 62.

FIG. 17 shows that a typical size of the large artery having dimensionda which is approximately 7 mm (inside diameter) and puncture site 44has an approximate opening size ap of approximately 2-3 mm. The lateraldistance between respective piercing edges 37, 37 a of needles 66, 68 isapproximately 5-6 mm. The lumen of the suture toggle delivery needles66, 68 is approximately 0.02 mm. Accordingly, the puncture for thesuture toggles is small compared with the size of the arterial puncturewhich in turn is smaller than the inside diameter da of large artery 31.

FIG. 18 diagrammatically shows delivery system 60 including a shapedelement 94 which forces needles 66, 68 to move laterally in thedirection of arrows 96 a and 96 b outboard and away from central tube62. Shape element 94 acts as a cam surface and needles 66,68 follow theproximal cam surface of the shape 94. The proximal end segments ofneedles 66,68 are attached to outer tube 80 which is further attached toscrew set 78. When outer tube 80 moves forward and aft over central tube62, the distal ends of needles 66, 68 move forward and aft over camshape surface 94. Cam shape element 94 is mounted on central base tube62. The following Needle Delivery Flare Table describes some shapes ofthe cam shape 94.

Needle Delivery Flare Table

ball

olive

oblong

frustoconical

angled ribs (with apex at a proximal end)

FIG. 19 diagrammatically shows an exploded view of delivery system 60.Thumb screw set 78 is attached to the proximal end of needle carryingtube 80. Needles 68, 68 are attached to carrying tube 80.

FIG. 20A shows needles 66, 68 from the perspective of section line20A′-20A″ in FIG. 19. The attachment of needles 66, 68 to needlecarrying tube 80 is shown in a cross-sectional view in FIG. 20B from theperspective of section line 20B′-20B″ in FIG. 19. The lumen 80a ofneedle carrying tube 80 is large enough to accommodate central tube 62.Central tube 62 extends through needle carrier tube 80.

Needles 66, 68 and needle carrying tube 80 are placed over central orbase tube 62. Guide wire 64 extends through lumen 63 of central tube 62when the system is deployed and in use.

FIG. 20C shows a cross-sectional view of central tube 62 from theperspective of section line 20C′-20C″ in FIG. 19. Needle retention body72 is mounted on central tube 62.

Needle retention body or structure 72 is mounted on central tube 62. Across-sectional view of one embodiment of needle retention body 72 isshown in FIG. 20D. FIG. 20D is a view from section lines 20D′-20D″ inFIG. 19. Needle cam shape 94 is attached to the distal end of centraltube 62 slightly beyond needle exit ports 98, 99 of needle retentionbody 72. It should be noted that needle retention body 72 may take oneor more of the shapes illustrated above in connection with FIGS. 16A,16B and 16C.

To construct the delivery system shown in FIG. 19, needle carrying tube80 and needles 66, 68 are placed over central tube 62. Needles 66,68 arefed into needle entrance ports 97 a, 97 b. Needles 66, 68 are placedinto the left and right side needle lumens of needle retention structure72 until they are proximate needle exit ports 98, 99. Thereafter, thumbnut set 76 is placed on the proximal end of central tube 62 by anappropriate attachment means (e.g., a thread). Accordingly, face 101 ofset 76, along section lines 102′-102,″0 is near or adjacent face 103 ofset 78 at se 104′-104″ which is the proximal end of thumb nut set 78. Ina preferred embodiment, thumb nut set 78 may cooperate with thumb nutset 76 to lock the needle delivery system and suture delivery systemtogether prior to deploying the system on guide wire 64. Afterdeployment, the system takes the configuration shown above in connectionwith FIG. 14B except central tube 62 includes a needle cam shape 94.This cam shape is absent from FIG. 14B.

At the time of suture toggle deployment, needle carrying tube 80 ismoved distally while central tube 62 remains stationary thereby causingneedles 66,68 to leave exit ports 98,99 and move over needle cam surfaceshape 94. At that time, the distal ends of needles 66, 68 move laterallyoutboard (relative to the axial center line) in the direction shown byarrows 96 a, 96 b in FIG. 18 until the piercing surfaces of needles 66,68 are distally beyond the needle cam shape 94. At that time, theoperator inserts the distal end of central tube 62 into arterialpuncture 44 shown in FIG. 17. Thereafter, needles 66, 68 pierce arterialwall 31, deposit the toggles in the artery's lumen and at the undersideof arterial wall 31 and the operator withdraws the needles by movingthumb nut set 68 proximally with respect to central tube 62 which ispreferably held stationary. This causes needles 66, 68 to withdraw andlaterally collapse since cam surface shape 94 no longer forces thedistal end of the needles to protrude laterally outward beyond centraltube 62. The needles are also drawn into needle retention body 72. Whenthe needles' terminal ends are at or near exit ports 98, 99, the entiredelivery system is withdrawn and the surgeon or physician ties off thesuture wire as shown in FIG. 7.

FIGS. 21-22 diagrammatically illustrate a toggle suture made of wire.This wire may be stainless steel wire. The toggle may also be memoryshape metal. In contrast, the sutures discussed above in connection withFIGS. 1-13 are made of nylon or other synthetic biocompatible material.

FIG. 21A shows suture wire 110 having a wire element toggle 114 atsuture terminal end 113. The wire is typically stainless steel but maybe an other type of biocompatible metal material. Wire element toggle114 includes a double strand segment 116. Wire element toggle 114 isangularly disposed, that is, disposed over angle 118 a with respect tothe axial central line of suture wire 110. In addition, wire elementtoggle 114 includes a depending wire tip section 118.

FIG. 21B shows wire element toggle 114 disposed on an inboard side ofbody structure, tissue or organ layer 31. Depending wire element 118protrudes into body layer 31 thereby locking or anchoring the togglesuture in place.

FIG. 21C shows wire suture 110 with a wire element toggle 114 beingnormal with respect to the suture wire. The angular disposition oftoggle 114 to the axial centerline of laid-out suture wire 110 isrelated to the needle delivery system and the spring action and toggleor latch action of the suture toggle.

FIG. 21D shows that depending leg 118 is angularly disposed at angle 121with respect to the central axis of wire element toggle 114. The angularposition is related to the needle delivery system and the degree oflocking necessary on bodily structure 31.

FIG. 21E shows suture wire 110 having a wire body 122 (about 16″-18″)and having toggle elements 114 a, 114 b attached to suture terminal ends113 a, 113 b.

FIG. 21F shows wire element toggle 114 attached by welding or other typeof mounting mechanism to suture terminal end 113.

FIG. 22A shows needle delivery system 124 which retains wire elementtoggle 114 and wire suture 112. Toggle element 114 includes an open loop135 and a linear segment 136. Linear segment 136 rests against theproximal end wall of a needle slot 130. Open loop toggles are shown inFIGS. 21E, 22A, C and D.

FIG. 22B shows needle 124 having a toggle needle slot 130 and wireelement toggle 114 having a depending leg 118 resting on toggle needleslot 130. Suture wire 110 is disposed in lumen 126 of needle 124. Leg118 is used to mount suture wire 110 in the delivery needle. Legs 119are shown in FIGS. 21A, 21B, 21D and 21F.

FIG. 22C shows toggle element 114 with open loop 135 disposed in toggleneedle slot 130.

FIG. 22D shows wire element toggle 114 in toggle slot 130 of needle 124.Needle 124 also includes a suture slot 134 through which runs wiresuture 110. Wire element toggle 114 is retained within toggle slot 130via its open loop. The operation of the wire suture and wire elementtoggle is substantially similar to the suture toggle discussed above inconnection with FIGS. 1-13. The operation and deployment of the suturetoggle and the suture needle is also similar to that discussed above inconnection with FIGS. 1-13.

FIGS. 23A, 23B and 23C diagrammatically show a delivery system 210 usedin connection with fascia 220 to deploy suture toggles in a mannerdiscussed above in connection with FIGS. 1-13 and 21-22. The deploymentdevice shown and described in connection with FIGS. 23-24 is typicallyused in laproscopic surgery. However, it maybe used whenever a surgeonneeds to suture fascia

Delivery system 210 includes handle 222 and central tube 224 whichcarries thread 226 at its distal end. Thread 226 coacts with threads onan inboard surface of collar 228. Collar 228 is attached to sutureneedles 230, 232. Suture needles 230, 232 move within needle passages inneedle retention body 234. This mechanical theory and feature isgenerally discussed above in connection with needle retention body 72and FIGS. 14A and 18.

Central body or tube 224 has a mid-section 224 a and a distal section224 b. At the distal end of distal section 224 b, a radially largefascia lift element 240 is mounted. A plunge cone 242 is mounted to thedistal end of enlarged lift segment 240. Fascia is lifted by theproxial, peripheral radial lip 240 a of lift element 240.

FIG. 23B diagrammatically shows an operational state of delivery system210. The distal ends 230 a , 232 a of needles 230, 232 protrude axiallybeyond the distal end of needle retainer 234. In operation, the suturetoggles are deposited in the fascia by rotational movement of body 224to collar 228 translated into axial movement and needle ends 230 a, 232a are withdrawn by counter rotation of central tube 224 thereby movingcollar 228 in a proximal direction. Withdraw of the suture needlescauses the suture toggles to remain embedded in the fascia.

FIG. 23C shows a delivery system 210 with suture wires 110 a, 110 bdisposed outboard of suture needle ends 230 a, 232 a. The suture wiresare run through capture channels 250,252 on either side of needleretention body 234.

FIG. 23D is a diagrammatic cross-sectional view from the perspective ofsection lines 23D′-23D″ in FIG. 23C. Suture capture body 252 capturessuture wire 110 b in a channel 254. Upon deployment of the toggle suturein the fascia, the physician simply moves the suture wire outboard ofthe channel 254 and closes the site.

FIGS. 24A, 24B and 24C diagrammatically illustrate the operation ofdelivery system 210. In FIG. 24A, cone 242 and fascia support or liftelement 240 have been inserted into a hole or cavity formed in fascia220. The surgeon or physician allows the fascia to rest thereby closingthe hole about distal cental rod segment 224 b.

In FIG. 24B, the physician gently raises delivery system 210 in thedirection shown by arrow 275. Lift element lip 240 a causes fascia 220to rise thereby lifting fascia 220 above underlying tissue elements 220a Further, the physician rotates central handle 224 with respect tocollar 228 thereby causing suture needles 230 a, 232 a to protrudebeyond the distal end of needle retention body 234.

In FIG. 24C, the physician has completely rotated handle 224 therebycompletely deploying needle ends 230 a, 232 a through fascia 220. Uponcomplete deployment of the toggle carrying sutures, the suture togglesengage the inboard edge or side of fascia 220 preferably in theinterstitial space between underlying material 220 a. The toggles arecaught by the fascia, leave the toggle carrying needles, latch onto theinboard surface of fascia 220 and remain in the fascia. The surgeon thencounter rotates handle 224 with respect to collar 228 therebywithdrawing suture needle ends 230 a, 232 a from fascia 220.Essentially, needles 230, 232 are withdrawn and recaptured by needleretention body 234. The surgeon then gently withdraws fascia liftelement 240 from fascia 220. The toggles are embedded in the inboardsurface of the fascia and the surgeon can then close the fascia.

FIGS. 25A, B, C and D diagrammatically illustrate a wire toggle with awire suture 310 and a wire toggle element 312. Toggle element 312 isconfigured as a hook with a crook or bend element 316 (0.008 orgreater), an angled body segment 314 and an end segment 318. End segment318 is generally in a plane parallel with respect to the axialcenterline of wire suture 310 assuming the suture is laid out straight.The length lt of hook end 318 is approximately 0.04. This configurationlocks onto the inboard surface of the bodily structure after the wiresuture is deployed beneath the surface. See generally FIG. 25D.

FIG. 25B illustrates toggle wire element 312 with a stepped radius orcurve consisting of proximal angled segment 320, normal segment 322(having a running length wr of about 0.020) and angled segment 323. Hookspan g from suture 310 to end segment 318 is about 0.60. FIG. 25C showshooked toggle 312 deployed in a delivery needle 324. In the illustratedembodiment, the needle does not have a suture slot.

FIG. 25D illustrates the deployment of hook toggles 312, 312 a and theintegral or attached wire sutures 310, 310 a twisted or crossed. In theconfiguration, the wire sutures are enabled to close the illustrated gapin body structure 340.

The claims appended hereto are meant to cover modifications and changeswithin the scope and spirit of the present invention.

What is claimed is:
 1. A self securing suture comprising a suture having at least one terminal end and a toggle at said terminal end, said toggle includes a catch element protruding therefrom and said suture is a thread of suture material and said toggle is a bar disposed one of generally normal to said suture thread and at an angle with respect to said suture thread.
 2. A suture as claimed in claim 1 wherein said suture has an outside diameter and said toggle has a generally solid rectangular shape and a width, a length and a depth, said width being substantially similar to said outside diameter of said suture and said length, normal to said suture thread, is at least five times larger than said outside diameter of said suture.
 3. A suture as claimed in claim 1 wherein said suture includes two terminal ends coupled together by said suture thread and includes respective toggle at each suture terminal end.
 4. A suture as claimed in claim 1 wherein said suture is made of suture thread material and said toggle is made of different biocompatible material.
 5. A self securing suture comprising a suture having at least one terminal end and a toggle at said terminal end, said toggle includes a catch element protruding therefrom and said toggle is a bar having a width, a length and a depth, and said catch element is an extending leg protruding from said toggle bar which forms a catch mouth in combination with said toggle bar.
 6. A suture as claimed in claim 5 wherein said protruding leg is formed from a partially separated segment of said toggle bar.
 7. A suture as claimed in claim 5 wherein said protruding leg extends outboard from said toggle bar away from said terminal end of said suture.
 8. A suture as claimed in claim 5 wherein said suture is a thread of suture material and said leg extends outboard substantially normal to said suture thread.
 9. A suture as claimed in claim 8 wherein said suture includes two terminal ends coupled together by said suture thread and includes respective toggle at each suture terminal end.
 10. A suture as claimed in claim 5 wherein said suture is a thread of suture material and said leg extends outboard from said toggle bar and inboard towards said suture thread.
 11. A suture as claimed in claim 10 wherein said toggle bar has opposing first and second ends, said leg and said toggle bar form said open catch mouth leading to a narrower throat, said catch mouth being open towards one of said first and said second bar ends.
 12. A suture as claimed in claim 5 wherein said suture includes two terminal ends coupled together by said suture thread and includes respective toggle at each suture terminal end.
 13. A suture as claimed in claim 5 wherein said suture is made of suture thread material and said toggle is made of different biocompatible material.
 14. A self securing suture comprising a suture having at least one terminal end and a toggle at said terminal end, said toggle includes a catch element protruding therefrom and said toggle is a bar having a width, a length and a depth, and said catch element includes an extending tab protruding from said toggle bar and said protruding tab extends outboard from said toggle bar away from said terminal end of said suture.
 15. A suture as claimed in claim 14 wherein said suture is a thread of suture material and said tab extends outboard substantially normal to said suture thread.
 16. A suture as claimed in claim 15 wherein said suture includes two terminal ends coupled together by said suture thread and includes respective toggle at each suture terminal end.
 17. A suture as claimed in claim 14 wherein said suture is a thread of suture material and said tab extends outboard from said toggle bar and inboard towards said suture thread.
 18. A suture as claimed in claim 14 wherein said toggle bar has opposing first and second ends, said tab is an extender bar protruding from said toggle bar and forming an open catch mouth for said catch element leading to a narrower throat, said catch mouth being open towards one of said first and said second bar ends.
 19. A suture as claimed in claim 14 wherein said toggle bar has opposing first and second ends, said tab is one of a solid triangular body, a finger and a conical body extending from a suture thread inboard toggle bar surface towards said suture thread, said tab having a raised terminal edge which faces away from said suture thread.
 20. A suture as claimed in claim 19 wherein said toggle bar carries a plurality of tabs.
 21. A suture as claimed in claim 14 wherein said suture includes two terminal ends coupled together by said suture thread and includes respective toggle at each suture terminal end.
 22. A self securing suture comprising a suture having at least one terminal end and a toggle at said terminal end, said toggle includes a catch element protruding therefrom and said suture includes two terminal ends coupled together by a suture thread and the self securing suture includes respective toggle at each suture terminal end.
 23. A self securing suture comprising a suture having at least one terminal end and a toggle at said terminal end, said toggle includes a catch element protruding therefrom and said suture is metal wire and said toggle is a wire element disposed on said suture terminal end wherein said wire toggle element includes a wire catch element depending therefrom.
 24. A suture as claimed in claim 23 wherein said wire element toggle includes a double strand segment between said suture wire and a terminal end of said wire element toggle.
 25. A suture as claimed in claim 24 wherein said catch element includes a depending wire section offset with respect to said wire toggle element.
 26. A suture as claimed in claim 23 wherein said wire element toggle is attached to said suture wire and said catch element includes a depending wire section offset with respect to said wire toggle element.
 27. A suture as claimed in claim 26 wherein said depending wire section is substantially normal to said wire suture.
 28. A suture as claimed in claim 23 wherein said catch element is an open wire loop element larger than said wire element toggle.
 29. A suture as claim 28 wherein said open loop element defines a linear segment thereon.
 30. A suture as claimed in claim 29 wherein said wire toggle element is disposed normally with respect to said wire suture and said linear segment is substantially parallel to said wire suture.
 31. A suture as claimed in claim 23 wherein said wire element toggle is attached to said suture wire and wherein said catch element defines an open loop element.
 32. A suture as claimed in claim 31 wherein said open loop element defines a linear segment thereon.
 33. A suture as claimed in claim 32 wherein said wire toggle element is disposed normally with respect to said wire suture and said linear segment is substantially parallel to said wire suture.
 34. A suture as claimed in claim 23 wherein said wire suture includes two terminal ends coupled together by a suture wire body and the self securing suture includes a respective toggle at each wire suture terminal end.
 35. A suture delivery system comprising a needle including a lumen, a piercing terminal end segment and an open ended slot, open at said piercing end segment, and a suture having at least one terminal end and a toggle at said suture terminal end, and a catch element protruding from said toggle, said catch element adapted to seat within said needle slot.
 36. A suture delivery system as claimed in claim 35 wherein said suture is a thread of suture material and said toggle is a bar disposed one of generally normal to said suture thread and at an angle with respect to said suture thread.
 37. A suture delivery system as claimed in claim 35 wherein said toggle is bar having a width, a length and a depth, and said catch element is an extending leg which protrudes from said toggle bar thereby defining a catch mouth for said needle slot.
 38. A suture delivery system as claimed in claim 37 wherein said suture is a thread of suture material and said leg extends outboard substantially normal to said suture thread.
 39. A suture delivery system as claimed in claim 38 wherein said toggle bar has opposing first and second ends, said leg and said toggle bar form an open catch mouth of said catch element leading to a narrower throat, said catch mouth being open towards one of said first and said second bar ends.
 40. A suture delivery system as claimed in claim 35 wherein said catch element is at least one extending tab and wherein said suture is a thread of suture material and said tab extends outboard forming a catch surface substantially normal to said suture thread.
 41. A suture delivery system as claimed in claim 40 wherein said toggle is a bar and said toggle bar has opposing first and second ends, said tab is one of a solid triangular body, a finger and a conical body extending from a suture thread inboard toggle bar surface towards said suture thread, said tab having a raised terminal edge which faces away from said suture thread.
 42. A suture delivery system as claimed in claim 41 wherein said toggle bar carries a plurality of tabs.
 43. A suture delivery system as claimed in claim 35 wherein said suture is made of suture thread material and said toggle is made of different biocompatible material.
 44. A suture delivery system comprising a needle including a lumen, a piercing terminal end segment and an open ended slot, open at said piercing end segment, and a metal wire suture having at least one terminal end and a wire element toggle disposed on said suture terminal end at an angle with respect to said suture wire and a catch element depending from said wire toggle element, said catch element adapted to seat within said needle slot.
 45. A suture delivery system as claimed in claim 44 wherein said wire element toggle includes a double strand segment between said suture wire and a terminal end of said wire element toggle.
 46. A suture delivery system as claimed in claim 44 wherein said catch element is an open loop wire element larger than said wire toggle element and wherein said open loop element defines a linear segment thereon, said linear segment adapted to seat in said needle slot.
 47. A suture delivery system as claimed in claim 46 wherein said wire element toggle is attached to said suture wire.
 48. A suture delivery system as claimed in claim 47 wherein said wire toggle element is disposed normally with respect to said wire suture and said linear segment is substantially parallel to said wire suture.
 49. A suture delivery system comprising a needle including a lumen, a piercing terminal end segment and an open ended slot, open at said piercing end segment, and a suture having at least one terminal end and a toggle at said suture terminal end, said toggle disposed at an acute angle with respect to said suture such that said toggle is adapted to be captured via said acute angle in said needle slot.
 50. A suture delivery system as claimed in claim 49 wherein said suture is a thread of suture material and said toggle is a bar of different biocompatible material.
 51. A suture delivery system as claimed in claim 49 wherein said toggle and said suture are made of similar biocompatible material and said toggle is stiffer than said suture.
 52. A suture delivery system comprising a needle including a lumen, a piercing terminal end segment and an open ended slot, open at said piercing end segment, and a metal wire suture having at least one terminal end and a wire element toggle disposed at an acute angle on said suture terminal end such that said toggle is adapted to be captured via said acute angle in said needle slot. 